Multimodal Intervention for Weight Management and Health in the Elderly Population

Change in Body Mass

Change in body mass from baseline to post-intervention. Body mass is assessed using multifrequency bioelectrical impedance analysis (InBody 570) and reported in kilograms (kg). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and after 16 weeks of intervention.

Change in lean mass

Change in lean mass from baseline to post-intervention. Lean mass is assessed using multifrequency bioelectrical impedance analysis (InBody 570) and reported in kilograms (kg). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and after 16 weeks of intervention.

Change in Appendicular Lean Mass

Change in appendicular lean mass from baseline to post-intervention. Appendicular lean mass is assessed using multifrequency bioelectrical impedance analysis (InBody 570) and reported in kilograms (kg). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and after 16 weeks of intervention.

Change in Fat Mass

Change in fat mass from baseline to post-intervention. Fat mass is assessed using multifrequency bioelectrical impedance analysis (InBody 570) and reported in kilograms (kg). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and after 16 weeks of intervention.

Change in Body Fat Percentage

Change in body fat percentage from baseline to post-intervention. Body fat percentage is assessed using multifrequency bioelectrical impedance analysis (InBody 570) and reported as a percentage (%). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and after 16 weeks of intervention.

Change in Skeletal Muscle Mass

Change in skeletal muscle mass from baseline to post-intervention. Skeletal muscle mass is assessed using multifrequency bioelectrical impedance analysis (InBody 570) and reported in kilograms (kg). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and after 16 weeks of intervention.

Change in Maximum Isometric Muscle Strength of the Upper Limbs

Change in maximum isometric muscle strength of the upper limbs from baseline to post-intervention. Maximum isometric muscle strength is assessed using the strength-testing procedure specified in the study protocol and reported in Newtons (N). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and after 16 weeks of intervention.

Change in Maximum Isometric Muscle Strength of the Lower Limbs

Change in maximum isometric muscle strength of the lower limbs from baseline to post-intervention. Maximum isometric muscle strength is assessed using the strength-testing procedure specified in the study protocol and reported in Newtons (N). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and after 16 weeks of intervention.

Change in Medicine Ball Throw Distance

Change in upper-limb rapid muscle performance from baseline to post-intervention is assessed using the Medicine Ball Throw Test. Participants perform a seated horizontal throw of a 2-kg medicine ball from chest level using a maximal explosive effort. The distance from the anterior edge of the chair to the point of first contact of the ball with the floor is measured using a metric tape. Three trials are performed, with a 60-second rest interval between trials, and the greatest distance achieved is used for analysis. Higher values indicate better upper-limb rapid muscle performance. Change in the greatest throwing distance is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and after 16 weeks of intervention.

Change in Timed Up and Go (TUG) performance

Change in functional mobility from baseline to post-intervention will be assessed using the Timed Up and Go (TUG) test. Participants will be instructed to stand up from a chair, walk the distance specified in the study protocol, turn around, return to the chair, and sit down. Performance will be recorded as the time required to complete the test, in seconds.

Time frame: Baseline and after the 16-week intervention

Change in lower-limb muscular endurance assessed by the 30-second Chair Stand Test

Lower-limb muscular endurance will be assessed using the 30-second Chair Stand Test. Participants will perform as many complete sit-to-stand repetitions as possible within 30 seconds. The total number of correctly completed repetitions will be recorded, with higher values indicating better muscular endurance.

Time frame: Baseline and after the 16-week intervention

Change in upper-limb muscular endurance assessed by the 30-second Arm Curl Test

Upper-limb muscular endurance will be assessed using the 30-second Arm Curl Test. Participants will perform as many complete elbow flexion and extension repetitions as possible within 30 seconds using a standardized dumbbell (2 kg for women and 4 kg for men). The total number of correctly completed repetitions will be recorded, with higher values indicating better muscular endurance.

Time frame: Baseline and after the 16-week intervention

Change in Fasting Plasma Glucose Concentration

Change in fasting plasma glucose concentration from baseline to post-intervention. Fasting plasma glucose is measured using an enzymatic colorimetric method and reported in milligrams per deciliter (mg/dL). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16

Change in Fasting Plasma Insulin Concentration

Change in fasting plasma insulin concentration from baseline to post-intervention. Fasting plasma insulin is measured by radioimmunoassay and reported in microunits per milliliter (µU/mL). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16.

Change in Fasting C-Peptide Concentration

Change in fasting C-peptide concentration from baseline to post-intervention. Fasting C-peptide is measured in fasting blood samples and reported in nanograms per milliliter (ng/mL). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16.

Change in Pulse Wave Velocity

Change in pulse wave velocity (PWV) from baseline to post-intervention. PWV is assessed as a measure of arterial stiffness and reported in meters per second (m/s). The outcome is calculated as the post-intervention value minus the baseline value. Lower PWV values indicate lower arterial stiffness.

Time frame: Baseline and after 16 weeks of intervention.

Change in Pulse Wave Transit Time

Change in pulse wave transit time (PWTT) from baseline to post-intervention. PWTT is assessed as the time required for the arterial pulse wave to travel between the predefined measurement sites and reported in milliseconds (ms). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and after 16 weeks of intervention.

Change in Fasting Triglycerides

Change in fasting triglyceride concentration from baseline to post-intervention. Fasting triglycerides are measured in blood samples and reported in milligrams per deciliter (mg/dL). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16.

Change in Fasting Total Cholesterol Concentration

Change in fasting total cholesterol concentration from baseline to post-intervention. Total cholesterol is measured in blood samples and reported in milligrams per deciliter (mg/dL). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16.

Change in Fasting High-Density Lipoprotein Cholesterol Concentration

Change in fasting high-density lipoprotein cholesterol (HDL-C) concentration from baseline to post-intervention. HDL-C is measured in blood samples and reported in milligrams per deciliter (mg/dL). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16.

Change in Fasting Low-Density Lipoprotein Cholesterol Concentration

Change in fasting low-density lipoprotein cholesterol (LDL-C) concentration from baseline to post-intervention. LDL-C is measured in blood samples and reported in milligrams per deciliter (mg/dL). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16.

Change in Fasting Very-Low-Density Lipoprotein Cholesterol Concentration

Change in fasting very-low-density lipoprotein cholesterol (VLDL-C) concentration from baseline to post-intervention. VLDL-C is reported in milligrams per deciliter (mg/dL). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16.

Change in Tumor Necrosis Factor Alpha (TNF-α) Concentration

Change in circulating tumor necrosis factor alpha (TNF-α) concentration from baseline to post-intervention. TNF-α is measured in blood samples and reported in picograms per milliliter (pg/mL). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16

Change in Interleukin-6 (IL-6) Concentration

Change in circulating interleukin-6 (IL-6) concentration from baseline to post-intervention. IL-6 is measured in blood samples and reported in picograms per milliliter (pg/mL). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16.

Change in executive cognitive function assessed by the Victoria Stroop Test - completion time

Executive cognitive function will be assessed using the Victoria Stroop Test, comprising three conditions: color, neutral words, and incongruent color words. Performance will be assessed by the time required to complete each condition.

Time frame: Baseline and after the 16-week intervention

Change in executive cognitive function assessed by the Victoria Stroop Test - errors

Executive cognitive function will be assessed using the Victoria Stroop Test. The number of errors made during the test will be recorded, with fewer errors indicating better performance.

Time frame: Baseline and after the 16-week intervention

Change in executive cognitive function assessed by the Trail Making Test - completion time

Cognitive function will be assessed using the Trail Making Test (TMT), including Parts A and B. Performance will be assessed by the time required to complete each part.

Time frame: Baseline and after the 16-week intervention

Change in executive cognitive function assessed by the Trail Making Test - errors

Cognitive function will be assessed using the Trail Making Test (TMT), including Parts A and B. The number of errors made during each part will be recorded, with fewer errors indicating better performance.

Time frame: Baseline and after the 16-week intervention

Change in Brain-Derived Neurotrophic Factor (BDNF) Concentration

Change in fasting plasma brain-derived neurotrophic factor (BDNF) concentration from baseline to post-intervention. BDNF is measured in fasting blood samples and reported in picograms per milliliter (pg/mL). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16

Change in Glucagon-Like Peptide-1 (GLP-1) Concentration

Change in fasting plasma glucagon-like peptide-1 (GLP-1) concentration from baseline to post-intervention. GLP-1 is measured in fasting blood samples and reported in picomoles per liter (pmol/L). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16

Change in Gastrin Concentration

Change in fasting plasma gastrin concentration from baseline to post-intervention. Gastrin is measured in fasting blood samples and reported in picograms per milliliter (pg/mL). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16.

Change in Peptide YY (PYY) Concentration

Change in fasting plasma peptide YY (PYY) concentration from baseline to post-intervention. PYY is measured in fasting blood samples and reported in nanograms per deciliter (ng/dL). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16.

Change in Leptin Concentration

Change in fasting plasma leptin concentration from baseline to post-intervention. Leptin is measured in fasting blood samples and reported in nanograms per milliliter (ng/mL). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16.

Change in 15-Item Geriatric Depression Scale Score

Change in depressive symptoms from baseline to post-intervention is assessed using the 15-item Geriatric Depression Scale (GDS-15). The GDS-15 consists of 15 items, with a total score ranging from 0 to 15 points. Higher scores indicate greater depressive symptom severity. Change in the GDS-15 total score is calculated as the post-intervention score minus the baseline score.

Time frame: Baseline and after 16 weeks of intervention.

Change in Beck Depression Inventory-II Total Score

Change in depressive symptom severity from baseline to post-intervention is assessed using the Beck Depression Inventory Second Edition (BDI-II). The BDI-II is a 21-item self-report instrument that assesses depressive symptoms experienced during the previous two weeks. Each item is scored from 0 to 3 points, resulting in a total score ranging from 0 to 63 points. Higher scores indicate greater severity of depressive symptoms. Scores are interpreted as follows: 0-13, minimal; 14-19, mild; 20-28, moderate; and 29-63, severe depressive symptom severity. Change in the BDI-II total score is calculated as the post-intervention score minus the baseline score.

Time frame: Baseline and after 16 weeks of intervention.

Change in Generalized Anxiety Disorder-7 Total Score

Change in anxiety symptom severity from baseline to post-intervention is assessed using the 7-item Generalized Anxiety Disorder scale (GAD-7). The GAD-7 consists of 7 items, each scored from 0 to 3 points, resulting in a total score ranging from 0 to 21 points. Higher scores indicate greater severity of anxiety symptoms. Change in the GAD-7 total score is calculated as the post-intervention score minus the baseline score.

Time frame: Baseline and after 16 weeks of intervention.

Change in WHOQOL-OLD Total Quality of Life Score

Change in quality of life from baseline to post-intervention is assessed using the World Health Organization Quality of Life-OLD (WHOQOL-OLD) instrument. The WHOQOL-OLD consists of 24 items covering six facets: Sensory Abilities, Autonomy, Past, Present and Future Activities, Social Participation, Death and Dying, and Intimacy. A total quality-of-life score is calculated according to the WHOQOL-OLD scoring procedure and transformed to a scale ranging from 0 to 100. Higher scores indicate better perceived quality of life. Change in the total transformed score is calculated as the post-intervention score minus the baseline score.

Time frame: Baseline and after 16 weeks of intervention.

Change in binge eating severity

Change in binge eating severity following the 16-week intervention. Binge eating symptoms will be assessed using the Brazilian validated version of the Binge Eating Scale (BES; Escala de Compulsão Alimentar Periódica \[ECAP\]). The instrument comprises 16 groups of statements addressing behavioral and affective features of binge eating. The total score ranges from 0 to 46, with higher scores indicating greater binge eating severity. The outcome will be analyzed as the change in total ECAP score from baseline to post-intervention.

Time frame: Baseline and after the 16-week intervention

Change in Predominant Readiness-to-Change Stage Assessed by the University of Rhode Island Change Assessment

Change in the predominant stage of readiness to modify dysfunctional eating behavior from baseline to post-intervention is assessed using the Brazilian adapted and validated version of the University of Rhode Island Change Assessment (URICA) for compulsive eating. The instrument comprises 24 items rated on a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree), and assesses four stages of the Transtheoretical Model of Change: precontemplation, contemplation, action, and maintenance. Responses are scored according to the instrument's scoring procedure to identify each participant's predominant motivational stage. The outcome is the change in predominant readiness-to-change stage from baseline to post-intervention, with progression toward action and maintenance indicating greater readiness and engagement in behavior change.

Time frame: Baseline and after 16 weeks of intervention.

Change in Appraisal of Self-Care Agency Scale Total Score

Change in self-care capacity from baseline to post-intervention is assessed using the Appraisal of Self-Care Agency Scale (ASA-A). The instrument comprises 24 items assessing self-care agency across physical, cognitive, and social aspects. The total score ranges from 24 to 120 points, with higher scores indicating greater self-care capacity. Change in the ASA-A total score is calculated as the post-intervention score minus the baseline score.

Time frame: Baseline and after 16 weeks of intervention.

Change in Total Daily Energy Intake

Change in total daily energy intake from baseline to post-intervention is estimated from food records. Total daily energy intake is expressed in kilocalories per day (kcal/day). Change is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and after 16 weeks of intervention.

Change in Protein Intake

Change in daily protein intake from baseline to post-intervention. Protein intake is estimated from food records and reported in grams per day (g/day). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16.

Change in Carbohydrate Intake

Change in daily carbohydrate intake from baseline to post-intervention. Carbohydrate intake is estimated from food records and reported in grams per day (g/day). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16.

Change in Fat Intake

Change in daily fat intake from baseline to post-intervention. Fat intake is estimated from food records and reported in grams per day (g/day). The outcome is calculated as the post-intervention value minus the baseline value.

Time frame: Baseline and post-intervention at week 16.

Change in Relative Autonomy Index for Exercise Motivation

Change in exercise motivational regulation from baseline to post-intervention is assessed using the Brazilian version of the Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3). The instrument comprises 23 items assessing six forms of behavioral regulation: amotivation, external regulation, introjected regulation, identified regulation, integrated regulation, and intrinsic motivation. Items are rated on a 5-point Likert scale ranging from 0 ("not true for me") to 4 ("very true for me"). A Relative Autonomy Index (RAI) is calculated from the six motivational regulation subscale scores using the following weighting: (-3 × amotivation) + (-2 × external regulation) + (-1 × introjected regulation) + (1 × identified regulation) + (2 × integrated regulation) + (3 × intrinsic motivation). Higher and more positive RAI scores indicate a more autonomous motivational profile for exercise. Change in RAI is calculated as the post-intervention score minus the baseline score.

Time frame: Baseline and after 16 weeks of intervention.

Change in Basic Psychological Needs in Exercise Scale Overall Score

Change in basic psychological needs satisfaction in the exercise context from baseline to post-intervention is assessed using the Brazilian version of the Basic Psychological Needs in Exercise Scale (BPNES). The instrument comprises 12 items covering three psychological needs: autonomy, competence, and relatedness, with 4 items assessing each need. Items are rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). For this outcome, an overall BPNES score is calculated as the mean of the 12 items, ranging from 1 to 5. Higher scores indicate greater overall satisfaction of basic psychological needs in the exercise context. Change in the overall BPNES score is calculated as the post-intervention score minus the baseline score.

Time frame: Baseline and after 16 weeks of intervention.